From the Guidelines
The starting dose of melatonin is usually 3 mg taken at bedtime 1.
Key Considerations
- The dose may be titrated up to address dream enactment in 3-mg increments to 15 mg 1.
- Immediate-release melatonin is recommended, as there is insufficient evidence to support the use of prolonged-release melatonin 1.
- Melatonin is considered a dietary supplement and is available over the counter in the United States and Canada, but its bioavailability and content may be less consistent across formulations 1.
- In clinical practice, combination therapy using clonazepam and melatonin is common if response to monotherapy is inadequate, although there is a paucity of data examining combination therapies 1.
Special Populations
- For older patients (> 50 years old) and those with neurodegenerative disease, melatonin is an intriguing option because it is only mildly sedating 1.
- The dosing of immediate-release melatonin to address dream enactment in secondary RBD is similar to that in isolated RBD, starting with 3 mg and increasing by 3-mg increments to 15 mg 1.
From the FDA Drug Label
PRINCIPAL DISPLAY PANEL - Vitamin Bottle Label Safrel Melatonin 3mg Tablets: The FDA drug label does not answer the question.
From the Research
Starting Dose of Melatonin
The starting dose of melatonin can vary depending on the individual and the specific condition being treated.
- In children with neurodevelopmental disorders, the starting dose of melatonin was 0.5 mg, which could be escalated to 2 mg, 6 mg, and 12 mg during the first 4 weeks of treatment 2.
- In healthy adults, a starting dose of 0.5 mg of melatonin was used to generate a phase response curve, with optimal administration times for advances and delays occurring in the afternoon, 2-4 hours before the dim light melatonin onset (DLMO) 3.
- In totally blind individuals with non-24-hour sleep-wake disorder, a low dose of 0.5 mg of melatonin was recommended, administered about 6 hours before the desired bedtime 4.
- In free-running blind people, a de novo dose of 0.5 mg of melatonin was able to capture their free-running rhythms within a few weeks 5.
- In older adults, the optimal dosage of melatonin supplementation is not well established, but it is recommended to use the lowest possible dose of immediate-release formulation melatonin to mimic the normal physiological circadian rhythm of melatonin 6.